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Volumn 2, Issue 4, 2007, Pages

When and how can endpoints be changed after initiation of a randomized clinical trial?

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL DECISION MAKING; CLINICAL PROTOCOL; CLINICAL RESEARCH; EVIDENCE BASED MEDICINE; MEDICAL DOCUMENTATION; METHODOLOGY; OUTCOME ASSESSMENT; OUTCOMES RESEARCH; PATIENT CARE; STATISTICAL ANALYSIS;

EID: 34249805427     PISSN: None     EISSN: 15555887     Source Type: Journal    
DOI: 10.1371/journal.pctr.0020018     Document Type: Article
Times cited : (60)

References (12)
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    • Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events): A randomized controlled trial
    • Dormandy J, Charbonnel B, Eckland D, Erdmann E, Massi-Benedetti M, et al. (2006) Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial In macroVascular Events): A randomized controlled trial. Lancet 366: 1279-1289.
    • (2006) Lancet , vol.366 , pp. 1279-1289
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  • 3
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    • Skyler JS (2005) PROactive results overstated and misleading. DOC News 2: 4.
    • Skyler JS (2005) PROactive results overstated and misleading. DOC News 2: 4.
  • 4
    • 3042714528 scopus 로고    scopus 로고
    • The prospective pioglitazone clinical trial in macrovascular events (PROactive): Can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients
    • Charbonnel B, Dormandy J, Erdmann E, Massi-Benedetti M, Skene A (2004) The prospective pioglitazone clinical trial in macrovascular events (PROactive): Can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients. Diabetes Care 27: 1647-1653.
    • (2004) Diabetes Care , vol.27 , pp. 1647-1653
    • Charbonnel, B.1    Dormandy, J.2    Erdmann, E.3    Massi-Benedetti, M.4    Skene, A.5
  • 6
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials
    • Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG (2004) Empirical evidence for selective reporting of outcomes in randomized trials. JAMA 291: 2457-2465.
    • (2004) JAMA , vol.291 , pp. 2457-2465
    • Chan, A.W.1    Hrobjartsson, A.2    Haahr, M.T.3    Gotzsche, P.C.4    Altman, D.G.5
  • 7
    • 4844223081 scopus 로고    scopus 로고
    • Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research
    • Chan AW, Krleza-Jeric K, Schmid I, Altman DG (2004) Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. Can Med Assoc J 171: 735-740.
    • (2004) Can Med Assoc J , vol.171 , pp. 735-740
    • Chan, A.W.1    Krleza-Jeric, K.2    Schmid, I.3    Altman, D.G.4
  • 8
    • 0037108040 scopus 로고    scopus 로고
    • On changing a long-term trial midstream
    • Wittes J (2002) On changing a long-term trial midstream. Stat Med 27: 2789-2795.
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    • The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low dose anticoagulation on obstructive changes in saphenous-vein coronary artery bypass grafts. The Post Artery Bypass Graft Trial Investigators
    • [No authors listed] (1997) The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low dose anticoagulation on obstructive changes in saphenous-vein coronary artery bypass grafts. The Post Artery Bypass Graft Trial Investigators. N Engl J Med 336: 153-162.
    • (1997) N Engl J Med , vol.336 , pp. 153-162
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    • The preliminary report of the findings of the aspirin component of the ongoing Physicians' Health Study. The FDA perspective on aspirin for the primary prevention of myocardial infarction
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    • (1988) JAMA , vol.259 , pp. 3158-3160
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    • Issues in the early termination of the aspirin component of the Physicians' Health Study. Data Monitoring Board of the Physicians' Health Study
    • Cairns J, Cohen L, Colton T, DeMets D, Deykin D, et al. (1991) Issues in the early termination of the aspirin component of the Physicians' Health Study. Data Monitoring Board of the Physicians' Health Study. Ann Epidemiol 1: 395-405.
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    • Journals should see original protocols for clinical trials
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    • Hawkey, C.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.